MICONAZOLE - Generic Drug Details
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What are the generic drug sources for miconazole and what is the scope of freedom to operate?
Miconazole
is the generic ingredient in nineteen branded drugs marketed by Janssen Pharma, Galt Pharms, Perrigo R And D, Medtech Products, Cosette, Actavis Mid Atlantic, L Perrigo Co, Insight Pharms, Perrigo, Taro, P And L, Teva, Teva Pharms, Actavis Pharma, Personal Prods, and Mylan, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.There are twenty-eight drug master file entries for miconazole. One supplier is listed for this compound.
Summary for MICONAZOLE
| US Patents: | 1 |
| Tradenames: | 19 |
| Applicants: | 16 |
| NDAs: | 32 |
| Drug Master File Entries: | 28 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Clinical Trials: | 31 |
| Drug Prices: | Drug price trends for MICONAZOLE |
| What excipients (inactive ingredients) are in MICONAZOLE? | MICONAZOLE excipients list |
| DailyMed Link: | MICONAZOLE at DailyMed |
Recent Clinical Trials for MICONAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 3 |
| Cairo University | Phase 3 |
| October 6 University | Phase 3 |
Pharmacology for MICONAZOLE
| Drug Class | Azole Antifungal |
Medical Subject Heading (MeSH) Categories for MICONAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for MICONAZOLE
US Patents and Regulatory Information for MICONAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medtech Products | MONISTAT 7 | miconazole nitrate | CREAM;VAGINAL | 017450-002 | Feb 15, 1991 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Medtech Products | MONISTAT 3 COMBINATION PACK | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 021261-003 | Jun 17, 2003 | OTC | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Medtech Products | MONISTAT 3 COMBINATION PACK (PREFILLED) | miconazole nitrate | CREAM;TOPICAL, VAGINAL | 021261-001 | Feb 2, 2001 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cosette | MICONAZOLE 7 COMBINATION PACK | miconazole nitrate | CREAM, SUPPOSITORY;TOPICAL, VAGINAL | 076585-001 | Mar 26, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Cosette | MICONAZOLE NITRATE | miconazole nitrate | CREAM;VAGINAL | 074366-001 | Feb 22, 1996 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MICONAZOLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galt Pharms | ORAVIG | miconazole | TABLET;BUCCAL | 022404-001 | Apr 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | ORAVIG | miconazole | TABLET;BUCCAL | 022404-001 | Apr 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Galt Pharms | ORAVIG | miconazole | TABLET;BUCCAL | 022404-001 | Apr 16, 2010 | ⤷ Sign Up | ⤷ Sign Up |
| Janssen Pharma | MONISTAT | miconazole | INJECTABLE;INJECTION | 018040-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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